ISO 13485 and Medical Devices

You need a Medical Device Solutions Partner Who Can...

Implement your requirements with ISO 13485 certified processes

Work within your quality management system
Provide value added services at any stage of your product development
Assure maximum return on investment for your early stage development efforts
Assist with your manufacturing process validations

Optimation is your Medical Device Solution Partner

From prototype, to product launch, to sustaining engineering, you need a partner that can provide medical device software design and development services that add value to your end product.

Why Choose Optimation for Your Medical Device Development?

We Provide Core Expertise

  • We develop product software on a variety of targets including embedded, mobile, real-time operating systems (RTOS), desktop and web
  • Our product software design and development services are compliant and ready for your 510(K) and PMA submission
  • We produce cGMP compliant and documented process automation and test systems for Class 1, Class II and Class III devices (across product lifecycle)
  • Our processes are validated and product software are verified
  • We understand choices between early stage budget limitations, level of concern and early stage design control requirements
  • We assist our client's in identifying the needed software functionality of their medical device and translating those needs into software requirements
  • We provide verification and validation solutions to assure our client's requirements are met
  • We provide guidance/assistance in the installation, operational and process qualifications of your production process

ISO 13485 Processes

Our processes are ISO 13485 registered, therefore you can be assured that the solutions we provide take into  consideration design history and review of potential risks related to the solution provided.  Our typical processes and solutions relating to medical device deliverables include:

Processes Solutions
Software Development
Application Software
Test Stands

Our risk review is based on your medical device risk assessment, we identify risks related to our medical device solution, for example:

  • What can go wrong
  • The likelihood of software/hardware failures and
  • Controls to detect and prevent the software/hardware failure or causes

We are Part of Your Team

Optimation's team of medical device software engineers have been providing these services for over 20 years, and have the knowledge and background needed to meet the stringent requirements pertaining to medical device development. Our engineers can work within your quality system, and if needed, can assist in your quality system development and improvement efforts.

Our Support is Available on Your Terms

Optimation has design and development centers in Houston, Minneapolis, Boston, Philadelphia, Dallas, Denver, Syracuse and Rochester, NY. This means you can have an onshore partner, in your timezone, or nearby.

With support tailored to your needs, Optimation can be there for your team - person to person or via web/teleconferences. You can depend on your project partner, Optimation, to be accessible, and with proven success for over 25 years, you can count on us to be there over your product lifecycle.

Medical Device Related Standards

  • ISO 13485
  • ISO 14971
  • IEC 62304
  • IEC 60601-1
  • 21 CFR Part 820
  • 21 CFR Part 11
  • TIR32, TIR36, TIR14969, TIR16142


''...Optimation satisfied ALL needs ... in a professional manner and executed every aspect of the Software Development Life Cycle for an FDA submission flawlessly. The development team is Class A, in managing multiple efforts, handling changing requirements, and maintaining compliance to a standard that meets or exceeds IEC62304:2006."

Kenny Long, Software Manager - Hospital Ventures
Medtronic MiniMed, Inc., Northridge, CA